LIDOCAINE AND PRILOCAINE cream

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R)

Διαθέσιμο από:

DIRECT RX

INN (Διεθνής Όνομα):

LIDOCAINE

Σύνθεση:

LIDOCAINE 25 mg in 1 g

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: -normal intact skin for local analgesia.-genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. lidocaine and prilocaine cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS). Lidocaine and prilocaine cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product. To measure 1 gram of lidocaine and prilocaine cream, the Cream should be gently squeezed out of the tube as a narrow strip that is 1.5 inches (3.8 cm) long and 0.2 inches (5 mm) wide. The strip of lidocaine and prilocaine cream should be contained within the lines of t

Περίληψη προϊόντος:

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is available as the following: NOT FOR OPHTHALMIC USE. KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE. Storage: Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. AKORN Distributed by: Akorn, Inc. Lake Forest, IL 60045 LN00N Rev. 06/12 Principal Display Panel Text for Container Label: NDC 17478-190-05 5 grams Lidocaine 2.5% and Prilocaine 2.5% Cream, USP Rx only Akorn Logo

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

LIDOCAINE AND PRILOCAINE- LIDOCAINE AND PRILOCAINE CREAM
DIRECT RX
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LIDOCAINE AND PRILOCAINE
DESCRIPTION SECTION
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is an emulsion in which
the oil phase is a eutectic
mixture of lidocaine and prilocaine cream in a ratio of 1:1 by weight.
This eutectic mixture has a
melting point below room temperature and therefore both local
anesthetics exist as a liquid oil rather
than as crystals. It is packaged in 5 gram and 30 gram tubes.
Lidocaine is chemically designated as acetamide,
2-(diethylamino)-N-(2,6-dimethylphenyl), has an
octanol: water partition ratio of 43 at pH 7.4, and has the following
structure:
Prilocaine is chemically designated as propanamide,
N-(2-methylphenyl)-2-(propylamino), has an
octanol: water partition ratio of 25 at pH 7.4, and has the following
structure:
Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg,
prilocaine 25 mg,
polyoxyethylene fatty acid esters (as emulsifiers),
carboxypolymethylene (as a thickening agent),
sodium hydroxide to adjust to a pH approximating 9, and purified water
to 1 gram. Lidocaine and
prilocaine cream contains no preservative, however it passes the USP
antimicrobial effectiveness test
due to the pH. The specific gravity of lidocaine and prilocaine cream
is 1.00.
CLINICAL PHARMACOLOGY SECTION
Mechanism of Action: Lidocaine and prilocaine cream applied to intact
skin under occlusive dressing,
provides dermal analgesia by the release of lidocaine and prilocaine
from the cream into the epidermal
and dermal layers of the skin and by the accumulation of lidocaine and
prilocaine in the vicinity of
dermal pain receptors and nerve endings. Lidocaine and prilocaine are
amide-type local anesthetic
agents. Both lidocaine and prilocaine stabilize neuronal membranes by
inhibiting the ionic fluxes
required for the initiation and conduction of impulses, thereby
effecting local anesthetic action.
The onset, depth and duration of dermal analgesia on intact skin
provided by lidocaine and prilocaine
cream depend p